DepressionSCOPENCT04350814
The Self-Compassion Online - Preventing Depression Trial
A study testing Self-Compassion Step by Step in people with Depression, run by University of Regina at 2 sites in Canada.
Trial summary
Purpose: Depression affects 12.6% of Canadians at some point in their life. Depression is associated with staggering personal and economic costs. There are several treatments that have been shown to treat episodes of depression when they occur. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Depression
- What is being tested?
- Self-Compassion Step by Step
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2020to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in the study, participants must be: a) 18 years old or older; b) have experienced at least one episode of depression; and c) exhibit elevated residual symptoms of depression-as indicated by a score of 5 or more on the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001). As the majority of people experience both depression and anxiety symptoms concurrently, participants experiencing elevated anxiety symptoms will not be excluded from the study.
Who cannot join
- Participants will be excluded from the study if they indicate: a) a current diagnosis MDD, substance use disorder, psychosis, or mania in accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5; American Psychiatric Association, 2013); b) the presence of major health conditions (e.g., cardiovascular diseases, cancer, hypothyroidism, etc.); and c) currently undergoing psychological or pharmacological treatment at the time of recruitment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Efficacy of a Self-Compassion Intervention to Prevent Relapse and Recurrence of Depression: Fostering Trait Resilience to Disrupt the Cycle of Depression
Purpose: Depression affects 12.6% of Canadians at some point in their life. Depression is associated with staggering personal and economic costs. There are several treatments that have been shown to treat episodes of depression when they occur. Unfortunately, more than half who respond to these treatments go on to re-experience an episode of depression. Even with psychological and pharmacological interventions designed to prevent future episodes, relapse and recurrence of the disorder remain alarmingly high. A patient-focused and self-directed intervention that harnesses the effects of an Eastern-influenced concept, called self-compassion, has shown tremendous promise in treating acute depression. Self-compassion is being moved by one's own suffering, and a desire to alleviate such suffering.
Objectives: In the proposed project, the investigators will examine whether a self-compassion intervention is effective in preventing relapse/recurrence of depression over a 12-month period among people who are at high risk for relapse. The investigators will also examine whether the intervention works to prevent depression by increasing the innate ability to bounce back from stress, a concept known as resilience.
Read more
Methodology: 120 participants with a history of depression will be randomly assigned to the self-compassion intervention or a self-assessment reflection condition, and their respective relapse rates will be examined over a period of 12 months.
Importance to Research: This will be the first study to examine the effects of self-compassion as a preventive intervention for depression.
Impact on health: If successful, this new intervention can be used by thousands of people in Saskatchewan and Canada who are at risk for depression relapse.
- Conditions
- Depression
- Being tested
- Self-Compassion Step by Step, Self-Reflection Active Control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion Step by StepBehavioural
This is a 6-lesson self-guided audio program by Dr. Kristen Neff (2013)
Self-Reflection Active ControlBehavioural
Participants randomized to this active control condition will be asked to complete study measures at the same intervals as those assigned to the intervention condition. In addition to completing study questionnaires, participants in this arm will also be invited to reflect on their weekly reported symptoms, whether they experienced changed, what they believe these changes are attributed to, etc.
| Study group | Role | What they receive |
|---|---|---|
| Self-Compassion Intervention Arm | Experimental | Participants randomized to this condition will receive access to the audio Mindful Self-Compassion self-help intervention. The intervention is 7 weeks in duration (with a pacing of one lesson per week) and participants are asked to complete study measures once each week of the intervention. Receives: Behavioral: Self-Compassion Step by Step |
| Self-Reflection | Active comparator | Participants randomized to this active control condition will be asked to complete study measures at the same assessment intervals as those in the experimental arm. In addition to completing the measures, participants in the Self-Reflection Active Control condition will be asked to reflect on their self-reported symptoms and changes they may have experienced between assessment intervals. Receives: Behavioral: Self-Reflection Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Interval Follow-UP Evaluation - Structured Clinical Interview (LIFE-SCID)
Proportional rates of individuals meeting criteria for major depression episode in accordance with the LIFE-SCID post randomization over 12-months across two conditions.
This measure is a diagnostic interview: Outcomes are binary (diagnosis vs. no diagnosis)
Measured: 12 Months
Weeks to Relapse
Time in weeks to confirmed MDE relapse during the assessment period
This is a linear calculation of how many weeks participants stayed diagnosis free (higher is more weeks without a depressive relapse/recurrence).
Measured: 12 Months
Scores on the Patient Health Questionnaire - 9 over 12-months
Differences in depressive symptoms among those randomized to the intervention or active control condition at the 12-month assessment period
This measure is a diagnostic interview: Outcomes are binary (diagnosis vs. no diagnosis)
Measured: 12 Months
Secondary outcomes (4)
Self-Compassion Scale (SCS)
This is a measure of dispositional self-compassion. Scores range from 12-60, with higher scores indicative of greater dispositional self-compassion.
Measured: Post-intervention, 3, 6, 9, and 12 Months
Five-Facet Mindfulness Questionnaire-15
This is a measure of dispositional mindfulness skills. Scores range from 15-75, with higher scores indicative of greater dispositional mindfulness.
Measured: Post-intervention, 3, 6, 9, and 12 Months
Experiences Questionnaire-Decentering
This is a measure of dispositional decentring abilities (viewing all experiences, including internal experiences, as passing events). Scores range from 12-48, with higher scores indicative of greater decentring.
Measured: Post-intervention, 3, 6, 9, and 12 Months
Fears of Compassion Scales (FCS)
This is a measure of the fear of showing one's self compassion. Scores range from 10 to 50, with higher scores indicative of greater fears of self compassion.
Measured: Post-intervention, 3, 6, 9, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Mar 2020
- Primary completion1 Dec 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will randomly assign participants to one of two conditions, and monitor their symptoms for 12 months. After the 12-months assessment period is complete, the investigators will offer the intervention to participants assigned to the active control condition to use at their own discretion.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, University of Amsterdam, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Shadi Beshai, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350814
- Sponsor's protocol ID
- 2018-229
- Acronym
- SCOPE
- Status last verified
- May 2024
- First submitted
- 14 Apr 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Self-Compassion Intervention to Prevent Relapse and Recurrence of Depression: Fostering Trait Resilience to Disrupt the Cycle of Depression
- ClinicalTrials.gov ID
- NCT04350814
- Acronym / sponsor ID
- SCOPE / 2018-229
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, University of Amsterdam, University of Oxford
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: Depression affects 12.6% of Canadians at some point in their life. Depression is associated with staggering personal and economic costs. There are several treatments that have been shown to treat episodes of depression when they occur. Unfortunately, more than half who respond to these treatments go on to re-experience an episode of depression. Even with psychological and pharmacological interventions designed to prevent future episodes, relapse and recurrence of the disorder remain alarmingly high. A patient-focused and self-directed intervention that harnesses the effects of an Eastern-influenced concept, called self-compassion, has shown tremendous promise in treating acute depression. Self-compassion is being moved by one's own suffering, and a desire to alleviate such suffering.
Objectives: In the proposed project, the investigators will examine whether a self-compassion intervention is effective in preventing relapse/recurrence of depression over a 12-month period among people who are at high risk for relapse. The investigators will also examine whether the intervention works to prevent depression by increasing the innate ability to bounce back from stress, a concept known as resilience.
Methodology: 120 participants with a history of depression will be randomly assigned to the self-compassion intervention or a self-assessment reflection condition, and their respective relapse rates will be examined over a period of 12 months.
Importance to Research: This will be the first study to examine the effects of self-compassion as a preventive intervention for depression.
Impact on health: If successful, this new intervention can be used by thousands of people in Saskatchewan and Canada who are at risk for depression relapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The investigators will randomly assign participants to one of two conditions, and monitor their symptoms for 12 months. After the 12-months assessment period is complete, the investigators will offer the intervention to participants assigned to the active control condition to use at their own discretion.
| Arm | Type | Receives |
|---|---|---|
| Self-Compassion Intervention Arm | Experimental | Behavioral: Self-Compassion Step by StepParticipants randomized to this condition will receive access to the audio Mindful Self-Compassion self-help intervention. The intervention is 7 weeks in duration (with a pacing of one lesson per week) and participants are asked to complete study measures once each week of the intervention. |
| Self-Reflection | Active comparator | Behavioral: Self-Reflection Active ControlParticipants randomized to this active control condition will be asked to complete study measures at the same assessment intervals as those in the experimental arm. In addition to completing the measures, participants in the Self-Reflection Active Control condition will be asked to reflect on their self-reported symptoms and changes they may have experienced between assessment intervals. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible to participate in the study, participants must be: a) 18 years old or older; b) have experienced at least one episode of depression; and c) exhibit elevated residual symptoms of depression-as indicated by a score of 5 or more on the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001). As the majority of people experience both depression and anxiety symptoms concurrently, participants experiencing elevated anxiety symptoms will not be excluded from the study.
Key exclusion criteria (1 listed)
- Participants will be excluded from the study if they indicate: a) a current diagnosis MDD, substance use disorder, psychosis, or mania in accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5; American Psychiatric Association, 2013); b) the presence of major health conditions (e.g., cardiovascular diseases, cancer, hypothyroidism, etc.); and c) currently undergoing psychological or pharmacological treatment at the time of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Compassion Step by StepThis is a 6-lesson self-guided audio program by Dr. Kristen Neff (2013) | Behavioural | Self-Compassion Intervention Arm |
| Self-Reflection Active ControlParticipants randomized to this active control condition will be asked to complete study measures at the same intervals as those assigned to the intervention condition. In addition to completing study questionnaires, participants in this arm will also be invited to reflect on their weekly reported symptoms, whether they experienced changed, what they believe these changes are attributed to, etc. | Behavioural | Self-Reflection |
Primary outcome
Longitudinal Interval Follow-UP Evaluation - Structured Clinical Interview (LIFE-SCID)
Time frame: 12 Months
Proportional rates of individuals meeting criteria for major depression episode in accordance with the LIFE-SCID post randomization over 12-months across two conditions. This measure is a diagnostic interview: Outcomes are binary (diagnosis vs. no diagnosis)
Weeks to Relapse
Time frame: 12 Months
Time in weeks to confirmed MDE relapse during the assessment period This is a linear calculation of how many weeks participants stayed diagnosis free (higher is more weeks without a depressive relapse/recurrence).
Scores on the Patient Health Questionnaire - 9 over 12-months
Time frame: 12 Months
Differences in depressive symptoms among those randomized to the intervention or active control condition at the 12-month assessment period This measure is a diagnostic interview: Outcomes are binary (diagnosis vs. no diagnosis)
4 secondary outcomes
Self-Compassion Scale (SCS)
Time frame: Post-intervention, 3, 6, 9, and 12 Months
Five-Facet Mindfulness Questionnaire-15
Time frame: Post-intervention, 3, 6, 9, and 12 Months
Experiences Questionnaire-Decentering
Time frame: Post-intervention, 3, 6, 9, and 12 Months
Fears of Compassion Scales (FCS)
Time frame: Post-intervention, 3, 6, 9, and 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shadi Beshai, PhD principal investigator
University of Regina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion Step by Step in people with Depression, run by University of Regina at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Interval Follow-UP Evaluation - Structured Clinical Interview (LIFE-SCID) (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.